Validation Engineer Job in Cincinnati 45201, Ohio US
JOB DESCRIPTION:
Overview:
Provide leadership to validation projects. Prepare process validation protocols, analyze data, and prepare validation summary reports. Monitor validation processes to ensure strict accordance with protocols and SOPs. Investigate and troubleshoot processing issues and provide written documentation of findings, recomendations, and conclusions. Perform physical testing of finished products, including tablet weight analysis.
Responsibilities:
- Write process validation protocols using information gained from technical services, research and development, and engineering, that clearly and succinctly define the process and test functions to be executed.
- Monitor validation processes to ensure strict accordance with protocols and SOPs.
- Review and interpret analytical and physical data. Evaluate process issues and determine performance trends.
- Summarize and evaluate validation findings in a clear, orderly, and succinct manner.
- Evaluate validation results such that the analysis is presented in a clear, orderly and succinct manner.
- Provide validation support for scale-ups and technical support as needed.
- Lead project teams.
- Provide project team support.
- Participate in routine validation activities (e.g., SOPs, Safety Training).
- Perform physical testing, using lab equipment, to complete test functions.
- Identify and communicate technical product or process issues.
- Troubleshoot and recommend solutions to mechanical, equipment, product, procedural and process problems as appropriate.
- Assist in training operators as required.
- Assess new manufacturing concepts and approaches.
Qualifications:
- BS in science or engineering
- 3+ years pharmaceutical validation experience
- Knowledge of all pertinent technical information related to an assigned product.
- Working knowledge of the operation of all manufacturing and/or packaging equipment for assigned projects.
- Thorough familiarity with cGMPs, SOPs, and relevant government regulations
- Ability to identify issues, potential manufacturing problems, review and judge data and provide suggestions as to improve.
- Working knowledge of Microsoft Office applications.
- Ability to communicate effectively at all levels of the organization.
- Ability to write validation protocols and evaluation reports.
- Clearly present data at team meeting (i.e. problem-solving meeting).
- Ability to track multiple projects.
- Ability to identify process or product problems and implement corrective actions.
